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EC number: 700-316-5 | CAS number: 1155405-88-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 95.89 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 18
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 13.89 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
The toxicity of Tri-C18-22 (even numbered)-alkyl 2-hydroxypropane-1,2,3-tricarboxylate was not specifically determined. But the structural related substance Tri (hexyl, octyl, decyl) citrate with shorter chain esters was investigated. The most appropriate endpoint for derivation of a DNEL is the rat oral NOAEL of > 1000 mg/kg bw/d taken from a well conducted subacute toxicity study of the structural related substance Tri (hexyl, octyl, decyl) citrate. Based on the acute toxicity data, DNELs do not need to be derived for local or systemic effects for the worker population since the material has a low potential for acute toxicity.
Worker long term exposure - systemic effects (dermal and inhalation) DNELs were calculated from the NOAEL, assuming a 100% dermal absorption rate (worst case). The value was divided by an adjustment factor of 72 (exposure duration factor of 6, interspecies factor of 4, and intraspecies (worker population) factor of 3), leading to a DNEL of > 13.89 mg/kg/d.
The corrected worker inhalation starting point was the corrected NOAEC of 1726 mg/m³ and was derived from the oral NOAEL of 1000 mg/kg/d by multiplying by the inverse of the standard respiratory volume of the rat during an 8 hour period (2.63) and multiplied by the ratio of standard respiratory volume for humans to the 8 hour worker standard respiratory volume (0.67). The corrected starting point was adjusted by a factor of 18 (intraspecies factor (worker) of 3, and exposure duration of 6), resulting in a calculated DNEL of > 95.89 mg/m³.
ASSESSMENT FACTORS:
The Assesment Factors are used according to Ecetoc Technical Report No 86 (ECETOC 2003).
Interspecies Assessment factors:
In addition to the allometric scaling factor of 4 a further interspecies assessment factor of 2.5 (remaining difference) is proposed in REACH Guidance R8, section R8.4.3.3, Table R.8-6, however no scientific basis for this is reported. In Ecetoc Technical Report No 86 (ECETOC 2003), a conclusion was reached that in the absence of a substance specific mode of action, allometric scaling based on metabolic rate is considered to provide an appropriate default assessment factor. As a specific mode of action has not been identified for Tri-C18-22 (even numbered)-alkyl 2-hydroxypropane-1,2,3-tricarboxylate it has not been considered necessary to apply this factor.
Intraspecies assessment factors: A factor for workers of 5 and for the general population of 10 has been suggested by the REACH guidance (8.4.3.1), however, based on several analyses of large data sets and in accordance with many workplace OEL setting practices an intraspecies factor for workers of 3 is considered appropriate for the worker population (ECETOC, 2003). Additionally following a review of human data which included both sexes and a variety of disease states and ages, the use of the 95th percentile is considered sufficiently conservative to account for intraspecies variability in the general population and thus a default assessment factor of 5 is recommended (ECETOC, 2003). ECETOC, 2003, Technical Report No. 86, derivation of Assessment Factors for Human Health Risk Assessment.General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 29 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
The toxicity of Tri-C18-22 (even numbered)-alkyl 2-hydroxypropane-1,2,3-tricarboxylate was not specifically determined. But the structural related substance Tri (hexyl, octyl, decyl) citrate with shorter chain esters was investigated.
The most appropriate endpoint for derivation of a DNEL is the rat oral NOAEL of > 1000 mg/kg bw/d taken from a well conducted subacute toxicity study. Based on the acute toxicity data, DNELs do not need to be derived for local or systemic effects for the general population since the material has a low potential for acute toxicity.
General population long term exposure - systemic effects (oral, dermal and inhalation) DNELs were calculated from the NOAEL, assuming a 100% dermal absorption rate (worst case). The value was divided by an adjustment factor of 120 (exposure duration factor of 6, interspecies factor of 4, and intraspecies (general population) factor of 5), leading to a DNEL of > 8.33 mg/kg bw/d.
The corrected general population inhalation starting point was the corrected NOAEC of 870 mg/m³ and was derived from the oral NOAEL of 1000 mg/kg/d by multiplying by the inverse of the standard respiratory volume of the rat during a 24 hour period (0.87). The corrected starting point was adjusted by a factor of 30 (intraspecies factor (general population) of 5, and exposure duration of 6, resulting in a calculated DNEL of > 29 mg/m³.
The general population oral starting point is > 1000 mg/kg/d. An adjustment factor of 120 is applied (interspecies factor of 4, intraspecies factor (general population) of 5, and exposure duration of 6), leading to a DNEL of > 8.33 mg/kg bw/day.
ASSESSMENT FACTORS:
The Assesment Factors are used according to Ecetoc Technical Report No 86 (ECETOC 2003).
Interspecies Assessment factors:
In addition to the allometric scaling factor of 4 a further interspecies assessment factor of 2.5 (remaining difference) is proposed in REACH Guidance R8, section R8.4.3.3, Table R.8-6, however no scientific basis for this is reported. In Ecetoc Technical Report No 86 (ECETOC 2003), a conclusion was reached that in the absence of a substance specific mode of action, allometric scaling based on metabolic rate is considered to provide an appropriate default assessment factor. As a specific mode of action has not been identified for Tri-C18-22 (even numbered)-alkyl 2 2-hydroxypropane-1,2,3-tricarboxylate it has not been considered necessary to apply this factor.
Intraspecies assessment factors: A factor for workers of 5 and for the general population of 10 has been suggested by the REACH guidance (8.4.3.1), however, based on several analyses of large data sets and in accordance with many workplace OEL setting practices an intraspecies factor for workers of 3 is considered appropriate for the worker population (ECETOC, 2003). Additionally following a review of human data which included both sexes and a variety of disease states and ages, the use of the 95th percentile is considered sufficiently conservative to account for intraspecies variability in the general population and thus a default assessment factor of 5 is recommended (ECETOC, 2003). ECETOC, 2003, Technical Report No. 86, derivation of Assessment Factors for Human Health Risk Assessment.Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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